Friday, January 27, 2012

Judge grants stay of preliminary injunction in Momenta Pharma case

By Lori Valigra

Momenta Pharmaceuticals Inc. (Nasdaq: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, was dealt a blow Thursday when the U.S. Court of Appeals for the Federal Circuit granted a motion for a stay of the preliminary injunction, pending appeal, from Amphastar Pharmaceuticals Inc., Watson Pharmaceuticals Inc. and International Medical Systems Ltd. Momenta has two patents for the process of making enoxaparin, the main Lovenox compound.

“While disappointing, this decision does not reflect a final ruling on the appeal or the ultimate case,” Craig Wheeler, president and CEO of Cambridge-based Momenta, said in a statement. “Any launch by Watson or Amphastar would be at risk and we continue to pursue our claims in the District Court. We have confidence in the strength of our patents.”

The company announced the stay on Oct. 28 last year. The preliminary injunction enjoined Amphastar, Watson and International Medical from offering to sell or selling their generic Lovenox blood-thinner drug before the District Court renders a decision in the ongoing litigation relating to the U.S. Patent No. 7,575,886.

In granting that motion, the District Court found that Momenta Pharmaceuticals demonstrated a reasonable likelihood of success on the merits of their claim that Patent No. 7,575,886 is valid and infringed by the competitor’s enoxaparin sodium product, Momenta noted at the time. But the grant of the preliminary injunction was subject to appeal.

A few days before that earlier ruling, on Oct. 24, Momenta announced that Sandoz confirmed it would launch an authorized generic version of Lovenox in the fourth quarter of 2011. Under terms of Momenta’s 2003 collaboration and license agreement with Sandoz, upon the launch and for the remainder of the product year ending June 30, 2012, Sandoz is obligated to pay Momenta a 10 to 12 percent royalty on its net sales of enoxaparin sodium until the contractual profits from those net sales reach a prorated amount of about $99.1 million. Provided that no other third party is marketing a generic Lovenox, Sandoz is obligated to pay Momenta 45 percent of contractual profits on net sales through the remainder of the product year ending June 30, 2012.

According to a Bloomberg news report, the court gave no reason for its stay, and Watson and Amphastar plan to begin sales immediately. A news release from Watson said the Federal Circuit said its order Thursday does not represent a final decision with respect to the merits of the pending appeal.

Momenta stock tumbled 21 percent on Thursday to $15.13, but nudged up this morning to $15.20. Bloomberg noted that the stock drop yesterday was Momenta’s biggest falloff since Sept. 19, when the U.S. Food and Drug Administration approved Amphastar’s Lovenox generic.

Momenta’s M-Enoxaparin, the first approved generic version of Sanofi’s Lovenox, has been expected to be a blockbuster. M-Enoxaparin brought in total U.S. sales of $292 million for the first 69 days on the market in 2010. Momenta shares these revenues with its partner Sandoz, the generics company of Swiss pharmaceutical firm Novartis AG.